Eosinophilic EsophagitisPhase 2NCT02098473
Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
A Phase 2 study testing RPC4046 in people with Eosinophilic Esophagitis, run by Celgene at 30 sites in 3 countries.
Trial summary
The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- RPC4046
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 31 Aug 2014to 30 Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic evidence of EoE
- Clinical symptoms of EoE including dysphagia
Who cannot join
- Primary causes of esophageal eosinophilia other than EoE
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States27 sites
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342
University of Colorado School of Medicine
Aurora, Colorado, 80045
Gastroenterology and Hepatology Service Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010
University of North Carolina
Chapel Hill, North Carolina, 27599
Metropolitan Gastroenterology Group Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
GI Associates and Endoscopy Center-GI Clinical Research Department
Flowood, Mississippi, 39232
University of Florida
Gainesville, Florida, 32608
Grand Teton Research Group
Idaho Falls, Idaho, 83404
Indiana University
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Borland-Groover Clinic
Jacksonville, Florida, 32256
Darthmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Great Lakes Gastroenterology Research
Mentor, Ohio, 44060
Vanderbilt University
Nashville, Tennessee, 37212
Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Alliance Clinical Research
Oceanside, California, 92056
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Minnesota Gastroenterology
Plymouth, Minnesota, 55446
University of Utah Division of Gastroenterology
Salt Lake City, Utah, 84132
Precision Research Institute, LLC
San Diego, California, 92114
Mayo Clinic - Arizona
Scottsdale, Arizona, 85259
Desert Sun Clinical Research, LLC
Tucson, Arizona, 85710
West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
Swiss EoE Clinic
Olten, 4600
Canada1 site
Gastrointestinal Research Group, University of Calgary Health
Calgary, Alberta, T2N 4Z6
About this study
Official title: A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis
The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- RPC4046, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPC4046Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| RPC4046 Low Dose | Experimental | intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose Receives: Drug: RPC4046 |
| RPC4046 High Dose | Experimental | intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose Receives: Drug: RPC4046 |
| Placebo | Placebo comparator | intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Eosinophil Count
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study start31 Aug 2014
- Primary completion17 Feb 2016
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098473
- Sponsor's protocol ID
- RPC02-201
- Status last verified
- May 2017
- First submitted
- 25 Mar 2014
- Last updated
- 9 May 2017
- Results posted
- No
Publications
Caldwell JM, Ballaban AY, Li J, Maddux R, Harris S, Dellon ES, Rothenberg ME. Cendakimab (anti-IL-13) administration improves esophageal gene expression in eosinophilic esophagitis. J Allergy Clin Immunol. 2026 Jan;157(1):118-130.e7. doi: 10.1016/j.jaci.2025.08.032. Epub 2025 Oct 9.
PubMed 41067281Dellon ES, Collins MH, Rothenberg ME, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, Straumann A, Safroneeva E, Rodriguez C, Minton N, Hua SY, Hirano I. Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):473-483.e17. doi: 10.1016/j.cgh.2020.03.036. Epub 2020 Mar 21.
PubMed 32205221Hirano I, Collins MH, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer AM, Straumann A, Safroneeva E, Grimm M, Smith H, Tompkins CA, Woo A, Peach R, Frohna P, Gujrathi S, Penenberg DN, Li C, Opiteck GJ, Olson A, Aranda R, Rothenberg ME, Dellon ES; HEROES Study Group. RPC4046, a Monoclonal Antibody Against IL13, Reduces Histologic and Endoscopic Activity in Patients With Eosinophilic Esophagitis. Gastroenterology. 2019 Feb;156(3):592-603.e10. doi: 10.1053/j.gastro.2018.10.051. Epub 2018 Nov 2.
PubMed 30395812
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02098473
- Acronym / sponsor ID
- RPC02-201
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2014 (actual)
- Primary completion
- 17 Feb 2016 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RPC4046 Low Dose | Experimental | Drug: RPC4046intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose |
| RPC4046 High Dose | Experimental | Drug: RPC4046intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose |
| Placebo | Placebo comparator | Drug: Placebointravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologic evidence of EoE
- Clinical symptoms of EoE including dysphagia
Key exclusion criteria (1 listed)
- Primary causes of esophageal eosinophilia other than EoE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPC4046 | Drug | RPC4046 High Dose, RPC4046 Low Dose |
| Placebo | Drug | Placebo |
Primary outcome
Mean Eosinophil Count
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Derived from this study: PubMed 41067281Caldwell JM, Ballaban AY, Li J, Maddux R, Harris S, Dellon ES, Rothenberg ME. Cendakimab (anti-IL-13) administration improves esophageal gene expression in eosinophilic esophagitis. J Allergy Clin Immunol. 2026 Jan;157(1):118-130.e7. doi: 10.1016/j.jaci.2025.08.032. Epub 2025 Oct 9.
- Derived from this study: PubMed 32205221Dellon ES, Collins MH, Rothenberg ME, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, Straumann A, Safroneeva E, Rodriguez C, Minton N, Hua SY, Hirano I. Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):473-483.e17. doi: 10.1016/j.cgh.2020.03.036. Epub 2020 Mar 21.
- Derived from this study: PubMed 30395812Hirano I, Collins MH, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer AM, Straumann A, Safroneeva E, Grimm M, Smith H, Tompkins CA, Woo A, Peach R, Frohna P, Gujrathi S, Penenberg DN, Li C, Opiteck GJ, Olson A, Aranda R, Rothenberg ME, Dellon ES; HEROES Study Group. RPC4046, a Monoclonal Antibody Against IL13, Reduces Histologic and Endoscopic Activity in Patients With Eosinophilic Esophagitis. Gastroenterology. 2019 Feb;156(3):592-603.e10. doi: 10.1053/j.gastro.2018.10.051. Epub 2018 Nov 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RPC4046 in people with Eosinophilic Esophagitis, run by Celgene at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Switzerland, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Eosinophil Count (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098473, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.